Status:
UNKNOWN
Efficacy of Baclofen Vs Naltrexon in Achieving & Maintaining Abstinence in Alcohol Dependence.
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Alcohol Liver Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
ALD is the most common cause of liver cirrhosis in western world. In patients with ALD persistent alcohol intake is associated with increased mortality while cessation of alcohol consumption improve s...
Detailed Description
Aim and Objective: • To compare the efficacy of Naltrexone Vs Baclofen in achieving and maintaining 12-week abstinence in patients with alcohol associated liver cirrhosis with continued alcohol use ...
Eligibility Criteria
Inclusion
- All consecutive alcohol related compensated cirrhotic patients with continued alcohol consumption despite counselling in last 4 weeks aged between 18 - 65yrs
- Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013)
- History of recent recidivism / relapse
Exclusion
- Current HE
- Total Bilirubin \> 5 mg/dl
- Recent bleed
- Treatment with corticosteroids within the past 60 days
- Unwilling to participate
- Dependence on any other substance (except Nicotine)
- Psychotic disorder requiring treatment
Key Trial Info
Start Date :
December 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06175507
Start Date
December 25 2023
End Date
March 31 2025
Last Update
December 19 2023
Active Locations (1)
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1
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India, 110070